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Clinical Trials/NL-OMON30133
NL-OMON30133
Completed
Not Applicable

Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH): A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures - FAITH

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
broken hip
Sponsor
Erasmus MC, Universitair Medisch Centrum Rotterdam
Enrollment
150
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Adult men or women aged 50 years and older (with no upper age limit).
  • 2\. Fracture of the femoral neck confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
  • 3\. Any degree of displacement (i.e., undisplaced or displaced) of the femoral neck fracture that can be closed reduced.
  • 4\. Operative treatment of displaced fractures within 2 days (i.e., 48 hours) of presenting to the emergency room.
  • 5\. Operative treatment of undisplaced fractures within 7 days of presenting to the emergency room.
  • 6\. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
  • 7\. Anticipated medical optimalization for operative fixation of the hip by anesthesia and/or internal medicine team.
  • 8\. Provision of informed consent by patient or legal guardian.
  • 9\. Low energy fracture (defined as a fall from standing height).
  • 10\. No other major trauma.

Exclusion Criteria

  • 1\. Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
  • 2\. Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
  • 3\. Retained hardware around the affected hip.
  • 4\. Infection around the hip (i.e., soft tissue or bone).
  • 5\. Patients with disorders of bone metabolism other than osteoporosis (i.e., Paget\*s disease, renal osteodystrophy).
  • 6\. Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
  • 7\. Patients with Parkinson\*s disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
  • 8\. Likely problems, in the judgment of the investigators, with maintaining follow\-up.

Outcomes

Primary Outcomes

Not specified

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